数智化技术在药物临床试验中的应用与发展研究OA

With the rapid development of emerging technologies such as computer science,mobile communications,and artificial intelligence(AI),drug clinical trials are undergoing a progressive transformation toward informatization,digitalization,and intelligence,thereby improving trial quality,efficiency,and success rates.However,the application of digital and intelligent technologies in clinical trials also introduces new challenges and risks,including AI algorithmic bias,the use and management of intelligent devices and platform systems,and data security concerns.This article reviews the development path and current landscape of digital and intelligent clinical trials,discusses their main application scenarios and challenges,and proposes development strategies from the perspectives of standards,regulation,and practical implementation.The study aims to provide references for promoting the safe,standardized,and orderly development of digital and intelligent clinical trials in China.